secwatch.observer — SEC 8-K summary
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Issuer:     ACTUATE THERAPEUTICS, INC. (ACTU)
CIK:        0001652935
Form:       8-K
Filed at:   2024-12-17T23:59:59+00:00
Accession:  0001683168-24-008794
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Actuate Therapeutics: elraglusib Phase 2 meets primary endpoint; 1-year survival 43.6% vs 22.5% in mPDAC
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- 1-year survival rate 43.6% in elraglusib+GnP arm vs 22.5% in GnP alone (p=0.002); median OS 9.3 vs 7.2 months (HR=0.63, p=0.016).
- 37% reduction in risk of death; ORR 27.7% vs 20.5%; multiple patients with complete/partial responses and 100% target lesion reduction.
- Favorable safety profile; TEAEs and SAEs similar between arms; 2 patients with previously inoperable lesions successful resected.
- Trial fully enrolled (286 patients); topline data expected 1H 2025; planned FDA engagement for Phase 3 registration trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652935/000168316824008794/0001683168-24-008794-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652935/000168316824008794/actuate_8k.htm
  HTML page:      https://secwatch.observer/filing/0001683168-24-008794

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer